Bicycle Therapeutics announced updates on its nuzefatide pevedotin program, identifying 8mg/m² Q2W as the preferred monotherapy dose and successfully dosing the first patient in a Phase 2 pancreatic cancer trial.
Key takeaways
Phase 1/2 data in metastatic urothelial cancer showed a 40% confirmed ORR in EphA2+ tumors and 100% ORR in MMAE-naïve patients.
The combination of nuzefatide pevedotin and nivolumab was generally well tolerated with no Grade ≥3 TRAEs of clinical interest.
The Company identified 8mg/m² Q2W as the preferred dose for monotherapy development.
First patient was successfully dosed in the Phase 2 trial for recurrent pancreatic ductal adenocarcinoma (PDAC) in April 2026.
Preclinical data demonstrated potent anti-tumor activity in 10 of 14 PDAC patient-derived xenograft models.